Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA
Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.
BMJ Open. 2022 Feb 10;12(2):e057591. doi: 10.1136/bmjopen-2021-057591.
Integrating palliative care (PC) early in the illness course for patients with serious cancers improves their outcomes and is recommended by national organisations such as the American Society of Clinical Oncology. However, monthly visits with PC clinicians from the time of diagnosis can be challenging to implement due to the lack of specialty-trained PC clinicians and resources. Therefore, we developed a stepped care model to triage PC service based on patients' needs.
We are conducting a non-blinded, randomised trial to evaluate the non-inferiority of a stepped PC model compared with an early integrated PC model for improving patients' quality of life (QOL) at 24 weeks (primary outcome). Patients assigned to early integrated PC meet with PC every 4 weeks throughout their illness. Patients assigned to stepped PC have PC visits only at clinically significant points in their illness (eg, cancer progression) unless their QOL decreases, at which time they are 'stepped up' and meet with PC every 4 weeks throughout the remainder of their illness. Secondary aims include assessing whether stepped PC is non-inferior to early integrated PC regarding patient-clinician communication about end of life care and length of stay on hospice as well as comparing resource utilisation. Patients are recruited from the Massachusetts General Hospital Cancer Center, Boston, Massachusetts; Duke Cancer Center, Durham, North Carolina and University of Pennsylvania Abramson Cancer Center, Philadelphia, Pennsylvania. The target sample size is 510 patients.
The study is funded by the National Cancer Institute, approved by the Dana-Farber/Harvard Cancer Center Institutional Review Board and will be reported in accordance with the Consolidated Standards of Reporting Trials statement. We will disseminate results through professional society meetings, peer-reviewed publications and presentations to patient organisations.
NCT03337399.
为患有严重癌症的患者在疾病早期整合姑息治疗（PC）可改善其预后，并得到美国临床肿瘤学会等国家组织的推荐。然而，由于缺乏专业的 PC 临床医生和资源，从诊断开始每月与 PC 临床医生进行一次就诊可能具有挑战性。因此，我们开发了一种阶梯式护理模式，根据患者的需求对 PC 服务进行分诊。
我们正在进行一项非盲、随机试验，以评估阶梯式 PC 模型与早期综合 PC 模型相比在改善患者 24 周生活质量（QOL）方面的非劣效性（主要结局）。分配到早期综合 PC 组的患者在整个疾病过程中每 4 周接受一次 PC 治疗。分配到阶梯式 PC 组的患者仅在疾病的临床显著点（例如癌症进展）进行 PC 就诊，除非他们的 QOL 下降，此时他们会“升级”并在疾病的剩余时间内每 4 周接受一次 PC 治疗。次要目标包括评估阶梯式 PC 在患者与临床医生关于临终关怀和临终关怀时间的沟通以及资源利用方面是否不劣于早期综合 PC。患者从马萨诸塞州总医院癌症中心、马萨诸塞州波士顿；北卡罗来纳州杜克癌症中心和宾夕法尼亚大学艾布拉姆森癌症中心，宾夕法尼亚州费城招募。目标样本量为 510 例患者。
该研究由美国国立卫生研究院资助，得到了 Dana-Farber/Harvard 癌症中心机构审查委员会的批准，并将按照《临床试验报告统一标准》进行报告。我们将通过专业学会会议、同行评议出版物和向患者组织的演讲来传播研究结果。
NCT03337399。
Zotero 插件